# K150143: Normal Saline Flush

- Pathway: 510(k) (Traditional)
- Applicant: Nurse Assist, Inc.
- Decided: Aug 31, 2015 after 221 days
- Product code: NGT (Saline, Vascular Access Flush)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K984590 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111034: AM Usa 0.9% Sodium Chloride Flush Syringe, Am USA (2011) Summary page 4.

## Recalls of this device
- Oct 4, 2016 · Class I · Z-0926-2017: Potential contamination with B. cepacia.

## Indications for use
This device is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.

Source page: https://510kreport.com/device/K150143
Methodology: https://510kreport.com/methodology